AccessGUDID - DEVICE: Plasma Shield (27290019426022)

GUDID

Device Identifier (DI) Information

Brand Name: Plasma Shield
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PLA-04
Company Name: Plasmatica Ltd.

Primary DI Number: 27290019426022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532350462 *Terms of Use

Device Description: Plasma Shield Disposable Part (PLA-AG000031). GMDN description: Endoscope cold plasma antifogging support set. The Plasma Shield is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. The Plasma Shield device is designed for reducing laparoscopic lens fogging by performing cold plasma treatment of a laparoscope lens. The Plasma Shield device is a cold plasma-based device to be used in an operating room, prior to and during laparoscopic procedures. The cold plasma creates a super hydrophilic scope lens surface after treatment (aka activation). The device does not interact directly with the patient’s body. The Plasma Shield consists of these components and accessories: - The main system is a Reusable Part (RP) that generates the cold plasma required to treat the scope for defogging. - A Disposable Part (DP) – a single-use, sterilized component interfacing with the scope itself and used for each procedure (can be used multiple times within the same procedure for the same patient). The DP assembly includes a folded surgical drape and packaged in a pouch. A single-use, sterile anti-fog solution and foam is supplied together with the Disposable Part.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66668	Endoscope cold plasma antifogging support set	A collection of devices intended to be used during cold plasma antifog activation of an endoscope by providing: 1) a physical barrier between an endoscope cold plasma antifogging unit and the endoscope/sterile field; and 2) an antifog solution to complement cold plasma treatment. It includes a plastic drape with a dedicated plug-in component intended to shield the internal portion of the antifogging unit, and an antifog solution typically with an application sponge. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery
OCT	Anti Fog Solution And Accessories, Endoscopy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e24091d-329a-4cf9-94c0-03f45b28b81b
Public Version Date: March 07, 2025
Public Version Number: 2
DI Record Publish Date: May 17, 2023